Blood and Bad Policies

blood_driveYesterday we had a blood drive at work that was hosted by the American Red Cross. Donating blood is something everyone should consider doing because the need for donated blood is immense. According to the American Red Cross (ARC) there is a need for 44,000 blood donations each day and, in the U.S., there is someone in need of a donation every two seconds.

It is with this in mind that I headed down to the donation drive yesterday to do my part. When I got there I was, unfortunately, turned away because I currently have a pretty bad cough and the ARC requires you to be free of those symptoms before donating blood. This is to help minimize the potential transmission of any blood borne pathogens to those who receive transfusions. I understand the reasoning behind this and told them I’d try again in six months when they return.

When I left the donation area I stopped at the registration table to let them know that I had been deferred as a donor when another fellow who was registering to donate looked up and abruptly asked me “Why can’t you donate? Are you gay?” This question literally left me flummoxed. One, I didn’t know this guy, and two, even if I had known him, why would he ask if I was gay because I got deferred from donating blood. I engaged this guy in discussion just long enough to learn that he believed that homosexuality was immoral and to realize that I would not want to spend any serious time in conversation with him. He was, shall we say, an under-informed, over-opinionated individual with a very caustic way about him.

After this exchange I did go back to my office and do a little bit of research and it turns out that in 1983 the Food and Drug Administration (FDA) placed a ban on male blood donors who have had sexual contact with another male (MSM donors). This was in response to the Acquired Immune Deficiency Syndrome (AIDS) outbreak that began around that time when we didn’t know much about the Human Immunodeficiency Virus (HIV) or how to test for it but it was observed that there was a higher prevalence in the population of homosexual males.

ARC and three logosThe policy was a reaction to the incomplete information available at the time. We now have a much better understanding of the virus and all blood is tested for HIV before it is administered to anyone.  The fact is that with the number of donations needed to meet the demand it is silly to systematically exclude an entire group of individuals as donors. It makes far more sense to evaluate individual donors based their own risk profile. In fact the ARC, the American Association of Blood Banks (AABB), and America’s Blood Centers (ABC) are in agreement with me on this. In 2010 they presented a joint statement to the FDA in which they stated the following:

“ AABB, America’s Blood Centers (ABC) and the American Red Cross strongly support the use of rational, scientifically-based deferral periods that are applied fairly and consistently among blood donors who engage in similar risk activities.  Therefore, since 2006 our organizations have recommended a change in the Food and Drug Administration’s (FDA)  deferral criteria for prospective male blood donors who have had sexual contact with another male (MSM)… After reviewing the data and publications available since the above mentioned 2006 BPAC meeting, our organizations, which represent the blood banking and transfusion medicine community, maintain our recommendation that FDA amend the indefinite deferral currently in place for a male who has had sex with another male since 1977 to a 12-month deferral.  This change in policy would conform the deferral period for MSM with the deferrals for other similar high-risk sexual behavior.  For example, the current deferral period for individuals who have had sexual contact with an individual with HIV or viral hepatitis is 12 months.  In each of these cases, the vast majority of donors with prevalent infections will be positive by both antibody tests and nucleic acid amplification testing (NAT).  This remains true even with increased numbers of HIV-infected MSM, as recently reported by the Centers for Disease Control and Prevention.”

This sentiment was further echoed by the American Medical Association in a 2011 statement. So far the FDA has refused to change their policy despite the fact that three major scientific organizations who understand blood borne pathogens and the risk levels for transmission of these pathogens all recommend them doing so.  There is always the potential that a blood borne pathogen from any donor can be transmitted through a blood transfusion. Its all about managing that risk and the evidence shows that we are able to do so.

Finally, to those, like the fellow I spoke to yesterday, who think homosexuality is immoral, I am not here to argue your beliefs with you, however if you decline a necessary blood transfusion because it may have come from a gay man then any negative consequences are your own fault. Medical science cannot prevent injury that results from misguided obstinance. It is not possible to eliminate all risk from the transfusion process but transfusions have saved millions of lives. Furthermore to discriminate against an entire population is truly unscientific and more importantly it is unethical.


Modern versus traditional medicine

Last Tuesday (just shy of a week ago) I had surgery on my knee to address a torn meniscus, an injury I got because I went on a run after having spent the previous 15 years getting older.  I write about it here because I mentioned that I was having surgery to a guy who works at my gym. This guy is a proponent of traditional Chinese medicine and told me that I was doing myself a disservice by using conventional medicine because traditional Chinese medicine is superior. This, he said, was because traditional medicine has been around for thousands of years, whereas modern medicine has only been around for a few hundred.

Meniscus 1

My poor presurgical knee with its torn meniscus.

The procedure I had is properly referred to as a partial meniscectomy with a joint debridement. Basically that means that they used a scope to go in to my knee capsule and remove the flap of torn meniscus tissue then clean the area up. 

As serious as it sounds, the whole procedure only lasted about 30 minutes. I arrived at the hospital at 7:30 am and was back at home walking around by 11:30.

My post-surgical knee looking almost as good as new.

My post-surgical knee looking almost as good as new.

Prior to surgery it felt as though there was a homunculus with a jackhammer dwelling inside my knee and doing his best to destroy it. Now, a week after surgery, the only pain I feel is from the swelling caused by the procedure itself and that has diminished consistently each day.

The little jackhammering fellow that I imagined causing all the pain.

The little jackhammering fellow that I imagined causing all the pain.

It would be very easy to take this procedure for granted as a minor one but if you stop and think about it, they went into my knee, an area that is usually closed to the outside world, removed bad tissue, and then cleaned the area up all while I felt no pain.  This did not ever happen during the heyday of ancient “traditional” medicine, it happened because in the 19th century practitioners began to use a more systematic and scientific analysis of patient symptoms in the diagnosis of disease and pathology.

It’s true that ancient chinese medicine has been around for at least 2500 years. Chinese medicine encompasses things like Massage and acupuncture, which have been shown to be quite effective in pain management, and other procedures that do nothing beyond the placebo effect. The evidence that massage is effective for pain management is robust enough to suggest that it is a worthwhile adjunct to scientific medicine. This is not controversial though, because massage is often a regular part of the post-operative physical therapy regimen. It was prescribed to me as part of mine.  What’s important to remember is that despite its efficacy for pain management, massage is not doing anything to treat disease or pathology; it helps control the pain. It is the all-natural version of ibuprofen. Certainly worthy of taking seriously but not the end-all-be-all of medicine.

Had I opted to forego surgery and use “traditional” medicine I would still have excruciating pain in my knee and would need to manage it using massage or acupuncture. The pain relief would only last until the effects wore off then I would need to go back and do it again. A 45-minute massage at my local wellness center is $49 and that is not covered by my insurance if I just go on my own without real medical advice. You can see that this would be great for the person charging me for the massage but not really for me. I’d have to keep going back to get the benefit. The surgery I had means that they fixed the problem. I don’t need to go have surgery every week to keep the pain down.

I guess I see the appeal of the ancient therapy argument however I can’t escape the observation that up until very recent times people died of things like influenza by the hundreds of thousands and, with regard to surgery, even very minor surgical procedures would have been torturous.  Ancient therapies aren’t better simply because they are older, they have to work if we want to call them better. I don’t have anything against traditional practices or Chinese medicine if they work but, for my money, I am going to bet on the side that uses science.

Aspartame And Our Health

equal-frontAspartame is a pervasive ingredient that is used as a low-calorie sweetener in a wide range of food and beverages. I got into a discussion about it recently because I was drinking a Diet Mountain Dew, which is sweetened using aspartame, and was informed that instead of being helpful as a way to watch Calories it would actually make me gain weight and that it causes all kinds of other health problems. I’ve heard many of these claims before and, being the skeptic that I am, was is the antithesis of scientific skepticism.  So I decided to look into what the side-effects of aspartame might be.

Janet HullDoing a Google search, one of the first websites I came across was hosted by Janet Starr Hull who is the creator of the Aspartame Detox program. This page reinforced my skepticism because, while I know very little about Hull, her homepage begins by hawking her book, then immediately follows with a link to submit your case of how aspartame negatively affected you. In the next paragraph she tells a vivid, yet completely unverifiable tale about how she was misdiagnosed with Graves disease in the early 1990s but restored her health with her own detox program. This is all very reminiscent of the tactics used by Dudley LeBlanc to hawk Hadacol in the 1940s and by Super-Charlatan Kevin Trudeau in all of his bogus blatherings. Furthermore, Hull refers to herself as Dr. Hull but is vague about her professional credentials, her website states that she has a doctorate in nutrition but she does not say from where, which sets off my skeptic alarms even further:  One can purchase a Ph.D based on life experience for $849.  I am not accusing Hull of purchasing her doctorate but since she is not forthcoming on her website about where she received it we can’t easily tell. After a little digging I found that she got a Ph.D in holistic nutrition from the Clayton College of Natural Health, which, before it closed was an unaccredited institution, that specialized in “alternative” medicine.  Finally, she promotes other things on her website that are definitely bogus. For example you can link to her online hair analysis program with the assurance that if you send in a hair sample it will help you detect any toxic chemicals in your system as well as nutrient and vitamin deficiencies. Hull’s credibility is definitely suspect but whether this because she is a charlatan or just overly-credulous I do not know for certain. I do, however, know that she is not an authoritative source and that I don’t trust her for objective information. The problem is that she has been cited in at least one research article as the source of claims about the ill-effects of aspartame. So, credible or not, she is evidently affecting public opinion about aspartame.

Aspartame chemical structureIt is with this in mind that I decided to look at some of the actual research on aspartame to see if there is any real concern to be had. Aspartame was discovered in 1965, and unlike other artificial sweeteners it is the only one that is completely broken down by the body into its constituent components: amino acids, aspartic acid, phenylalanine, and methanol.  All of these components are present in other foods and are used by the body the same way whether they come from aspartame or other sources.

With regard to potential side-effects, there was a study done in 2005 that did find that people who regularly drank diet sodas had a 41% increase in the chance of being overweight for every can or bottle of diet soft drink he or she consumed. This, however, says absolutely nothing about the role of aspartame in the process. Even the study’s authors concluded that soda is not the root of obesity and conclude that it may be something that is correlated with diet soda drinking that causes the weight gain. There are other concerns with aspartame, though. It has been speculated that aspartame may cause increased allergic reactions based on anecdotal reports of increased headache and other allergic signs and symptoms. However a study out of Duke University found no difference between placebo and aspartame groups in allergic signs. Other studies have confirmed that aspartame is no more likely than a placebo to cause allergic sensitivity.

One real potential problem with aspartame is that one of the constituent components is methanol. Methanol breaks down into formaldehyde, which then breaks down into Formic acid. These can be toxic to humans at high enough levels. However it has been shown that we break down and excrete formic acid faster than we accumulate it through consumption of aspartame.

There is more to this controversy but the fact is that Aspartame is one of the most studied and tested food additives ever approved by the U.S. Food and Drug Administration. It has been shown repeatedly that aspartame is safe for most people (there is a notable exception for those individuals with a condition called Phenylketonuria). So relax and enjoy your low calorie yogurt and your diet soda, just consume them in moderate amounts and you’ll be fine.

The Current Fear of Vaccines: Fraudulent science and the identifiable victim effect

Tetanus Painting by Sir Charles Bell, 1809.Last week a story circulated about a seven year old New Zealand boy named Alijah whose parents opted against vaccinating him and his siblings. They made this decision based on what they believed was solid evidence in favor of forgoing vaccination. Unfortunately Alijah got a small cut on the bottom of his foot in December of 2012 and contracted tetanus, an excruciating condition which ultimately led to the need to put him in an induced coma to stop his agony; agony that could have been entirely avoided if he’d received the tetanus vaccine. Alijah was in this coma for three weeks then had to learn to walk and to eat again once he came out of it.

Alijah’s parent were not bad people, they, like most parents, want the best for their children and made what they thought was the better decision regarding vaccinations. Further, and this is important to remember, they went public about their error so that others might avoid making the same mistake. That is not an easy mistake to admit as a parent so they deserve a lot of credit for their candor.

The question of whether vaccines might be linked to harmful side-effects is not new; there have been religious arguments against vaccination since the process began. In 1798 an Anti-vaccination Society was formed by physicians and clergymen, who called on the people of Boston to suppress vaccination, as “bidding defiance to Heaven itself, even to the will of God.” There are indeed still those who object to vaccinations for superstitious reasons but the current Andrew Wakefieldcontroversy is not religious, as least in an obvious sense. Rather it began with a paper that was published in the Lancet (a well-respected journal of repute!) by Andrew Wakefield in 1998. In his paper he concluded that there is an association between the MMR vaccine and the appearance of autism and bowel disease. This study was the impetus for the anti-vaccine movement and has led to a cultural shift regarding vaccines. The most salient fact, however, about this study, is that it was proven fraudulent and ultimately retracted by the journal and by 10 of the paper’s 13 authors.  In addition to the study being retracted, Wakefield’s license to practice medicine in the United Kingdom has been revoked by the British General Medical Council (GMC), for professional misconduct.  Nonetheless, the damage done by Wakefield continues; Last year in Britain there were 2,000 reported cases of measles, and this year there has already had been more than 1,200 reported. The group that is most affected by this disease is adolescents who were never vaccinated.  


Lancet retracted article

The fear of vaccines is not isolated to the United Kingdom or to New Zealand. In the United States, Jenny McCarthy has been an outspoken activist against the use of them for several years now. She has repeatedly made the claim that her son’s autism was caused by vaccinations. Unfortunately because of all of the above claims many people are now assuming that vaccines are harmful and opting out of vaccinating their kids. This is resulting in cases of otherwise preventable diseases being on the rise once again in the U.S.

jmcvaccinesThe problem with taking the advice of someone like Jenny McCarthy is that she is an entertainer and a public figure.  There is absolutely nothing wrong with that but being a public entertainer does not mean she has any expertise in public health or the biological sciences. So why do we give her opinions on autism and vaccines any consideration? Actually there is a very good, albeit unscientific, reason that her opinion carries so much weight. It is the result of something called the identifiable victim effect. This occurs when there is a victim of some ailment or event, in this case it is McCarthy whose son suffered from autism, who we can identify and empathize with. When McCarthy talks about her son in the public forum most of us, especially if we are parents ourselves, feel sympathy toward her plight as a struggling parent.  When she blames vaccines for her son’s autism and ultimately her struggles, it is hard not to want to boycott all vaccines.  

Among the myriad of problems with this line of reasoning are, as mentioned above, the fact that the only study showing an association between vaccines and autism has been proven fraudulent, and the fact that the identifiable victim in this case is Jenny McCarthy, who is not the actual victim of autism.  In reality there is not a single scientifically documented case of a vaccine causing autism, therefore many more people are harmed by avoiding the vaccines. These people are no more than statistics to most of us though so their plight is not nearly as vivid as McCarthy’s strife.

I hold no ill will towards Ms. McCarthy but her misguided rhetoric blaming vaccines—which are, in fact, one of the greatest achievements of scientific medicine—for the rise in autism is sadly misguided and is causing harm.

Morality and Fat?

Last week NYU psychology professor, Geoffrey Miller got himself into hot water for posting a tweet that read: “Dear obese PhD applicants: if you didn’t have the willpower to stop eating carbs, you won’t have the willpower to do a dissertation. #truth.”


Aside from Professor Miller’s clear lack of understanding of nutrition (it’s not just about carbs) his tweet brings up an important point regarding obesity. We here in the US don’t often treat obesity solely as a potential health problem, rather we treat it is a moral issue. This is the result of prejudice rather than reason and is not helpful at all to anyone who is trying to lose weight. So to address the question of whether we should be viewing body weight as a moral issue we really need to step away from our cultural perceptions and look at our biology.

Body fat is just stored energy, if you consume more energy than you expend, you store it as fat. Our bodies have evolved over several hundred thousand years to survive in our environment; one of the ways that we did so was to adapt a way to store food energy, which allowed us to eat enough to fuel both our present need and to store energy for later when the food supply may be scarce, like during periods of famine. Our DNA doesn’t know that those of us in the affluent middle classes of the developed world have regular access to far more Calories than we need (1). By influencing us to eat more than we need, our genes allow us to store energy for the future, which enables proper development and guards against starvation (2). One of the things that happen when we diet and lose weight is that our resting metabolism slows down. In other words our bodies get more efficient and use less energy, which is certainly a good adaptation to prevent starvation, but a major pain for those of us who want to lose weight (3). Our bodies don’t only slow down our metabolism when we cut back on calories and lose weight, they also signal us to be hungrier (4). Furthermore, there have been over 600 genes identified that play a role in weight gain and obesity (5).

Now, while it is true that our bodies have evolved to hold onto the food that we eat and drive us to eat more than we need, I am not suggesting that biology justifies us in abandoning our efforts to improve our health by eating well and making positive lifestyle choices; we are thinking animals and it is now, as it always will be our own responsibility to take care of ourselves.  I am, however, suggesting that if you are a person who struggles with your weight, you have not morally faltered. There will always be those who disagree with me on this point but I am curious as to what their goals actually are with weight loss. It is probably not health.

According to historian and author Peter Stearns (6) the attitudes in the United States about fat result from our cultural need to morally compensate for excessive and wasteful consumerism. The problem with this line of moral reasoning is that it creates an unfortunate paradox, because our biological drive to eat is motivated by the need to store energy for later, which, contrary to being wasteful, is, from the physiologic perspective, actually a very thrifty thing to do. In the case of body fat, our cultural and biological perceptions of thrifty behavior are in dynamic conflict with each other.

Attaching morality to this problem can cause us to believe that unsuccessful attempts at weight loss are an indication of our own moral shortcomings, which can lead us to search for implausible or even harmful alternative solutions.  If, however, we keep in mind that weight loss is a physical and mental challenge that has nothing to do with our moral value it is possible to see that it is completely unwarranted to deem our lives unworthy simply because we have to struggle with something.

So to Professor Miller I say this: Get your biases and prejudices under control, Sir before you post foolish comments for the world to see. You are free to be a sanctimonious pedant in your private life but as an academic and a potential thought leader you have a responsibility to demonstrate better critical thinking.


  1. Statistics from the Food and Agriculture Organization of the United States. Data spreadsheet available at:…/FoodConsumptionNutrients_en.xls
  2. Tooby, J., Cosmides, L. 1990. “The Past Explains the Present: Emotional Adaptations and the Structure of Ancestral Environments.” Ethology & Sociobiology, 11: 375-424.
  3. Leibel, R. Rosenbaum, M., Hirsch, J. 1995. “Changes in Energy Expenditure Resulting from Altered Body Weight.” New England Journal of Medicine, March 9 332(10): 621-628.
  4.  Jhanwar-Uniyal, M., Beck, B., Jhanwar, Y.S., Burlet, C., Leibowitz, S.F. 1993. Neuropeptide Y projection from arcuate nucleus to parvocellular division of paraventricular nucleus: specific relation to the ingestion of carbohydrate. Brain Research 631:97-106. This study shows one of the mechanisms by which our bodies make us hungrier when calories are low an increase in a neurotransmitter called neuropeptide Y, which causes cravings for carbohydrate, a quick energy source, to increase. This stuff gets released in really high amounts during calorie reduction, which is, of course, interpreted by the body as starvation.
  5. Pérusse L, Rankinen T, Zuberi A, Chagnon YC, Weisnagel SJ, Argyropoulos G, Walts B, Snyder EE, Bouchard C. The human obesity gene map: the 2004 update. Obes Res. 2005 Mar;13(3):381-490.
  6. Stearns, P. Fat History: bodies and beauty in the modern west. 1997. New York, NY :New York University Press.

Operational Definitions and Health

Operational definitions are clear, detailed, and yet concise definitions of given measures. Their intended purpose is to minimize confusion that can result from more variable or nebulous definitions.  Operational definitions have an important place in the health sciences but can be very difficult to delineate. Think about this: what does it mean to be healthy?

According to the World Health Organization (WHO), Health encompasses three dimensions: It is a complete state of physical, mental, and social well-being and not merely the absence of disease or infirmity. This is a useful definition if we look at health from a high-level, epidemiologic perspective, but it can be difficult to apply to ourselves as individuals. We all have days when we don’t feel like we are complete on all of these dimensions. Does that mean we aren’t healthy on those days? The answer is maybe but not necessarily.

Most of us have an operational definition of health the not only encompasses being free from disease or disorder but also some degree of overall wellness, which echoes the WHO’s definition. But what does wellness mean, then? Wellness generally includes both physical and mental health. But what does it mean to be mentally healthy…? I could do this all day but I won’t. I hope, though, that it illustrates the difficulty involved in coming up with a meaningful operational definition of good health.

Charlatan trudeauI started thinking about operational definitions in this context because I recently read that Kevin Trudeau, the sociopathic swindler behind the whole series of “They” don’t want you to know about conspiracy books, recently declared bankruptcy to avoid paying $37 million in fines to the federal government and now faces potential incarceration. These fines were originally levied because he defied a 2004 settlement with the FTC in which he was banned from peddling any products other than his books because of fraudulent  claims that he and his infomercial costar, “Dr.” Robert Barefoot (another self-aggrandizing quack), made about coral calcium being a cure for cancer. Trudeau had been off of my radar for a while but hearing about him again reminded me of something he wrote in his  digest of misinformation Natural Cures “They” Don’t Want You To Know About, that always stuck with me as a perfect example of why it is important to think about operational definitions when it comes to making decisions about our health. In his book, Trudeau offers what is perhaps the most unattainable definition of good health that I have ever seen. According to Trudeau:

An ideal scenario would be waking up in the morning full of energy and vitality, content, and feeling absolutely great. You go throughout your day with energy, a bounce in your step, a smile on your face. You don’t feel stressed, anxious, or depressed’ you don’t feel tired, you have no headaches or pain in your body’ you are not overweight and you don’t get colds or flus or sickness. You don’t get diseases, you have no pain, you’re not ravenous with your appetite, you eat what you want and you are never that hungry. You don’t deprive yourself of the foods you enjoy. You go to sleep at night and you sleep soundly and peacefully and get a wonderful whole night’s rest. Your sexual desires are healthy and strong, and you are capable of both giving and receiving sexual pleasure. Your skin, your hair, and your nails look healthy and radiant. You have strength and tone in your muscles, your body is fluid, graceful, and flexible. You are firm, strong, vibrant, and feel great! (pg 11)

Sure this would be ideal, however it is pretty clear that Trudeau is either profoundly unaware of the human experience—nobody feels that good all of the time—or that he is creating a market for himself. If we believe his definition of what it means to be healthy then we will inevitably feel unhealthy most of the time. Trudeau, who despite his general sleaziness is very good at the game that he plays, then has the opportunity to assuage the concern that he contrived for us by making unsubstantiated claims then selling us books about them. Trudeau is a highly visible hack but there are many others who use the same tactics.

Mental-HealthIn fact, it is entirely normal to have some mood variation throughout the day. A 2007 study by Katerndhal and colleagues, showed that healthy patients without an underlying mood disorder such as depression or panic disorder, experience maximum and minimum mood levels throughout the day that reflect their circadian rhythm. Further these same healthy people also have additional mood fluctuations in response to sporadic stressors. The point is that variable moods, and stress levels are a normal part of good mental and physical health.

Furthermore, with regard to stress levels, if we are never exposed to both physical and mental stresses, we can become very unhealthy.  On the physical side, think about exercise:  the reason we need to do it is because we need to stress our bodies by overloading them in order to stay in good condition. On the mental side, there is a great deal of emerging evidence that we can maximize our cognitive function by keeping our brains and bodies active.

So despite the fact that it is tough to define health, a good place to start is first with the absence of disease, then with the WHO’s definition of physical, mental, and social activity. However it is important that we also account for the fact that we aren’t going to be in top form all of the time; further someone who is free from disease and able to recover from bouts, even prolonged bouts, of poor physical, mental, or social acuity likely has a good prognosis with regard to his overall health and wellness.

Health science is an objective physical science so I do not mean to imply that we should choose a subjective and unfalsifiable definition of health that fits any situation; this would be as ridiculous as any claim made by Trudeau and his ilk. There are, in fact, a variety of risk factors that can rob us of our physical and mental health and shorten our time on earth. I merely mean to imply that we should all remember that un-scientific charlatans like Kevin Trudeau, Robert Barefoot, and the plethora of other self-serving nostrum peddlers out there have only their own interests in mind and are using operational definitions that meet their own needs at the expense of ours.

For more scientific info about health risk factors see the WHO’s report on global health risks at:

Dietary Supplements: Shifting the Burden to Create a Pathway for Fraud week I have spent a significant time around a lot of people who have colds. This is a really bad week for me to be sick so I am thus currently very interested in preventative measures. I mentioned this to numerous people and was told by a few different folks that I should try taking Airborne, a dietary supplement that was developed by a former schoolteacher to help boost the immune system and prevent the onset of illness. I did, of course, express immediate skepticism that a dietary supplement, which is nothing more than a vitamin tablet, would keep me from getting sick. In fact, just a little digging showed that in 2008 the makers of Airborne agreed to pay $23 million to settle a class action false-advertising lawsuit. Based on my own experience this didn’t surprise me at all, however the conversation piqued my interest as to why so many folks feel better taking dietary supplements than medications. The answer to this question was not hard to find. Many people prefer supplements over drugs because they simply don’t trust the pharmaceutical industry. Between several largely publicized cases of unethical behavior and the laundry list of potential side-effects we are inundated with at the end of most drug commercials (which are required by the FDA to be listed) many people feel like drugs and medications are not worth the risk. The pharmaceutical industry is far more scientific than the dietary and nutritional supplement industry; however I am no pharmaceutical apologist. That is an industry that has done a lot to earn our mistrust (more in a later post about this topic). The point I want to make in this post is that the nutritional supplement industry does not deserve our trust either. Current regulations in the U.S. allow supplement manufacturers to make basically any claim without any verification of the efficacy of that claim. Further, the tactics the supplement industry uses to market their products are extremely misleading.

According to the Food, Drug, and Cosmetic Act the term ”drug” can mean any substance recognized in the official United States Pharmacopoeia and/or substances that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals. It can also refer to any substance other than food that is intended to affect the structure or any function of the body of humans or other animals.

A dietary supplement has a somewhat different definition. In 1994 the Dietary Supplement and Health Education Act (DSHEA) was passed by congress. Under the DSHEA a dietary supplement is defined as:

“a ‘dietary ingredient’ intended to supplement the diet. The ‘dietary ingredients’ in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of ‘foods,’ not drugs, and requires that every supplement be labeled a dietary supplement.”

So the difference between a drug and a supplement lies in the fact that their purported intentions are different: drugs can treat disease and supplements augment the diet. In reality, the line distinguishing the two has become very blurry in recent years; supplements are now being advertised in the same way drugs are and for the same types of things. I cite Airborne’s claim that it increases the immune response and prevents colds as a perfect example of this.

The most significant difference between drugs and dietary supplements, however, lies in the way they are developed and approved. In the U.S. the drug approval process stipulates that the manufacturer of a drug provide the FDA with evidence that the compound is biologically active, and reasonably safe for initial administration to humans. Once this requirement has been met, there are three phases of further research to determine the efficacy and safety of the drug. Finally, if it makes it this far, meetings are held in order to uncover any unresolved problems or issues, and then the drug and research is subjected to review by outside sources and advisors before any approval is made by the FDA. The process of drug approval is not without controversy and corruption but it is at least scientific.

Dietary supplements on the other hand are subjected to far less scrutiny than drugs, due in large part to the DSHEA. The intentions behind the DSHEA were to help increase the availability of certain nutrients to consumers, but it also led to a boom in the marketing of unsubstantiated claims. Before the bill was signed into law, dietary supplements were subject to regulation by the FDA. Now, however, it is the manufacturer who is responsible for determining that a given dietary supplement is safe and that any representations or claims made about it are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed and that a manufacturer does not have to provide FDA with evidence to substantiate safety or effectiveness to market its products.

The problem inherent in the DSHEA is that it puts the burden of proof in the wrong place. Those who stand to make a great deal of money from a product need, from a scientific standpoint, to be the ones who are responsible to demonstrate that it is safe and effective before they market it, the DSHEA however, relieves them of that responsibility. The Federal Trade Commission (FTC) deals with false advertising claims, but as long as the manufacturers remain clever there is little the FTC can do.

Scientific research is eventually conducted on many supplements and there are several that have been shown to be effective for their intended purpose. However it is wise to remember is that even when supplements are effective, they are ultimately limited in their scope. The problem is that many of the more profitable supplements are on the market long before there is enough evidence to support their efficacy and safety, so it is often a crapshoot as to whether one will turn out to work. Furthermore, there is also the bigger problem of manufacturers simply misrepresenting the evidence.

xenadrineMy first experience as a research assistant made me acutely aware of this problem. In 2000 I was a research assistant at Eastern Michigan University where we examined the effect of the product Xenadrine RFA-1, which was a nutritional supplement that was ephedrine based and was purported to aid in weight loss. Ephedrine is currently banned from use in dietary supplements in the U.S., but at the time it was one of the hottest weight loss products available. During the study, which was funded by Cytodyne Technologies (the supplement manufacturers) we had subjects take either the supplement or a placebo and walk six miles per week to see if the supplement led to greater weight loss than the placebo. What we found was that the supplement group lost a little more weight than the placebo group, but that the difference was not statistically significant, meaning that the difference in our study was due to chance.

The actual amount of weight lost for the supplement group was 3.19 pounds. The representative for the company, however, told the principal investigator that we should report our findings by saying that the supplement group lost 759% more weight than the placebo group who actually had an average weight gain of just less than half a pound. Reporting the numbers this way would have been mathematically accurate but very misleading. The principal investigator, being an ethical researcher, refused to do this after which the company threatened legal action. The legal action didn’t get anywhere but, not to be thwarted, Cytodyne later ran a magazine advertisement in which they blatantly misrepresented the results of our research. This garnered the attention of Dr. Robert Robergs, the editor of the Journal of Exercise Physiology Online, which is where we published our original findings, who had this to say in an editorial that appeared in the May, 2002 issue of the journal:

The authors of this study presented their data in an ethical fashion.  However, subsequent use of the study findings for marketing of the product revealed claims that were not substantiated by the research published in our journal. Subsequent discussions by the managing editor of the journal, myself and the ASEP [American Society of Exercise Physiologists] president revealed frustration for this occurrence, as well as an apparent inability to require the company to withdraw marketing claims due to the lack of regulations requiring companies to adhere to the stringent criteria used in scientific research… It needs to be made clear that in no way does ASEP support or condone the use of any commercial product that is the focus of research published in any of its journals.

In a related article that appeared in the journal, Professionalization of Exercise Physiology Online, editor Tommy Boone describes how the company used an ad which appeared in an issue of Muscular Development to misrepresent our research.

As an example, the paid advertisement states that “…resting energy expenditure was greatly increased for the Xenadrine group.  This means that the Xenadrine subjects were burning far more calories without even exercising.”  Wrong!  The actual finding, as reported by the authors, is that “…resting energy expenditure…did not increase during the supplementation period….”  The authors did not report a statistically significant increase in resting energy expenditure.  The advertisement is nothing more than consumer fraud. . . the authors reported that “Analysis of…HDL cholesterol and LDL cholesterol revealed no effect of supplementation”.  In contrast, though, note the content of the advertisement published in May 2002 issue of Muscular Development – “…the placebo group in the Eastern Michigan study actually experienced lower ‘good’ HDL cholesterol…than the Xenadrine group [that] experienced lower ‘bad’ cholesterol than the placebo group…subjects who took Xenadrine improved their good cholesterol and lowered their bad.”  Quite stunning! Right.  The truth of the matter is none of the content is true.  Again, the authors reported no significant differences.

Even when research is conducted in a responsible fashion, there is not really anything to stop manufacturers from using the findings in any way they can to sell their products. The tactics of Cytodyne Technologies eventually landed them in a class-action lawsuit in California where they were ultimately forced to pay $12.5 million dollars in damages. In 2003 the New York Times reported some of the information that came out during the trial:

… an e-mail message in the Cytodyne lawsuit shows how the company tried to influence one researcher.

The researcher, Jeffrey Armstrong of Eastern Michigan University, had refused to rewrite a journal abstract the way the company wanted, according to testimony, and Tim Ziegenfuss, the consultant who commissioned the study on behalf of the company, said he would try to change Dr. Armstrong’s mind.

”As far as rewriting the abstract, since I am not recognized as a co-author on the study I am not allowed to do it,” Dr. Ziegenfuss said on November 2000 in an e-mail message to a company official. He added, ”In this case the best I can do is try to carefully nudge his interpretation/writing in Cytodyne’s favor.”

Cytodyne was unable to budge Dr. Armstrong — ”I will not be intimidated,” he said in an e-mail message after being told that the company was threatening to sue him. But in another message, Dr. Ziegenfuss suggested that the study could still be marketed.

”Let Jeff do his hum-drum ‘science’ thing,” he said.

”This will portray Cytodyne in an objective, favorable manner to the scientific community,” he added. ”This is particularly important now considering the recent bad press on ephedrine. And then since Jeff has no control over the use of data in ads, use percentage changes there to impress consumers.”

Manufacturers are not interested in “hum-drum” scientific findings that don’t support their claims and will often blatantly misrepresent themselves. This situation is not unique to Cytodyne and is certainly not likely to change in the near future. This means that the burden rests on consumers to evaluate the information for ourselves. I was a research assistant on this project and was not directly involved in any of the above events, but rather witnessed them from the sidelines. Looking back I have to admit that I find it rather amusing, in a sardonic sort of way, to think that I learned much more about commercial research from the drama that surrounded that project than I did working on the research itself.